The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

Replimune shares collapsed on Tuesday after the U.S. Food and Drug Administration rejected the clinical-stage biotechnology company's proposed advanced melanoma treatment. Shares of the Woburn, Mass., ...

Pierre Fabre leads global development of tab-cel, an innovative therapy for EBV+ PTLD, with ongoing trials and potential FDA ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.

Investing.com -- Ultragenyx Pharmaceutical (TADAWUL: 2070) Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete ...